Medical Device Single Audit Program (MDSAP)

Update: December 18, 2025

MDSAP Documents have been moved to the new MDSAP website managed by the Australia Therapeutic Goods Administration. Click here to be redirected.

The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale. At its inaugural meeting in Singapore in 2012, the IMDRF identified a work group to develop specific documents for advancing a Medical Device Single Audit Program (MDSAP).

The Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.

International partners that are participating in the MDSAP include:

MDSAP Members:
- Therapeutic Goods Administration of Australia
- Brazil’s Agência Nacional de Vigilância Sanitária
- Health Canada
- Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency
- U.S. Food and Drug Administration
MDSAP Official Observers:
- European Union (EU)
- Singapore's Health Sciences Authority (HSA)
- United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA)
- The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme
MDSAP Affiliate Members:
- Argentina's National Administration of Drugs, Foods and Medical Devices (ANMAT)
- Ministry of Health of Israel
- Kenya's Pharmacy and Poisons Board
- Republic of Korea's Ministry of Food and Drug Safety
- Federal Commission for Protection from Sanitary Risks (COFEPRIS) of Mexico
- South African Health Products Regulatory Authority (SAHPRA)
- TFDA - Taiwan Food and Drug Administration

From January 1, 2014 to December 31, 2016, the FDA, alongside its international partners, participated in a Medical Device Single Audit Program Pilot. On June 29, 2017, a report was generated summarizing the outcomes of prospective “proof-of-concept” criteria established to confirm the viability of the Medical Device Single Audit Program. The outcomes documented in the Final MDSAP Pilot Report are based on data generated during the three (3) year pilot.

Based on its evaluation of the MDSAP Final Pilot Report, the MDSAP Regulatory Authority Council (the international MDSAP governing body) determined that the MDSAP Pilot had satisfactorily demonstrated the viability of the Medical Device Single Audit Program.

The FDA may continue to accept MDSAP audit reports as a substitute for routine Agency inspections. Firms with activities related to the Electronic Product Radiation Control (EPRC) provisions of the Federal Food, Drug, and Cosmetic Act will continue to be subject to FDA inspections for the EPRC activities.

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